Cefoperazone

In response to the clinical treatment needs of multidrug-resistant Gram-negative bacterial infections, third-generation cephalosporin drugs have always been one of the core choices in the anti-infection field. Cefoperazone exerts bactericidal activity by inhibiting the biosynthesis of bacterial cell walls, and has strong effects on common pathogenic bacteria such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, etc. Clinically, it is mainly used to treat moderate to severe infections caused by sensitive bacteria, including respiratory tract infections, urinary tract infections, peritonitis, cholecystitis, and sepsis. It is especially suitable for anti-infection treatment of elderly infected patients with underlying diseases and people with low immune function, and is often combined with β-lactamase inhibitors to form compound preparations to improve antibacterial activity.

In 2023, the market size of systemic anti-infective drugs in China exceeded 280 billion yuan, among which cephalosporin drugs accounted for nearly 35%. As a core variety of third-generation cephalosporins, cefoperazone compound preparations had an annual sales volume exceeding 6 billion yuan, with a compound annual growth rate of 4.2% in the past 3 years. At present, the domestic cefoperazone preparation market is dominated by generic drugs, and relevant preparations of more than 30 enterprises have been approved for marketing. After the implementation of volume-based procurement, the average price reduction of single-component preparations reached 68%, the localization rate of upstream API has exceeded 90%, and North China and East China are the main production clusters.

The original developer of cefoperazone is Pfizer, with the original brand name "Cefobid". The core compound patent of cefoperazone expired globally in 2000. The main dosage form approved for the original product is cefoperazone sodium for injection, with specifications covering 0.5g, 1.0g and 2.0g. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by NMPA, and is also listed in the FDA Reference Preparations Catalogue. At present, cefoperazone APIs from nearly 20 domestic enterprises have obtained A status identification through CDE registration, and more than 50 cefoperazone single-component and compound preparations have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for cefoperazone API, with most products available from stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the R&D and production quality control needs of pharmaceutical enterprises in different scenarios such as API quality research, impurity profile analysis, and preparation consistency evaluation.